Label: DG ICE COLD ANALGESIC- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 23, 2011

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  • Active Ingredient

    Menthol (2%)

  • Purpose

    Topical Analgesic
  • Uses

    Uses-For the temporary relief of minor aches and pains in muscles and joints associated with:

    simple backache

    sports injuries

    strains

    arthritis

    sprains

    bruises

  • Warnings

    For external use only


  • DO NOT USE

     Do not use with other topical pain relievers

    with heating pads or heating devices

  • WHEN USING

    When using this product

    do not use in or near eyes

    do not apply to wounds or damaged skin

    do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if

    condition worsens

    symptoms last more than 7 days or clear up and occur again within a few days

    redness or irritation develops

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Clean affected area before applying product

    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

  • Inactive Ingredients

    carbomer, isopropyl alcohol, kathon CG, sodium hydroxide, thymol, water(aqua), FDandC blue no 1

  • PRINCIPAL DISPLAY PANEL

    Distributed by Dolgencorp, LLC
    100 Mission Ridge
    Goodlettsville, TN 37072

    MADE IN CHINA
    100% quality guaranteed
    (888) 309-9030
  • PRINCIPAL DISPLAY PANEL

    gellabelpdp

  • PRINCIPAL DISPLAY PANEL

    analgesicbacklabel
  • INGREDIENTS AND APPEARANCE
    DG ICE COLD ANALGESIC  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-815
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-815-08227 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34806/11/2010
    Labeler - Dolgencorp, LLC (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co Ltd530766098manufacture
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